510(k) · Cleared
ClearedM/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microline Surgical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Feb 8, 2016 as substantially equivalent to K980065 (C/T Med System, Ltd., 1998) after a 138-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- Feb 8, 2016
- Review
- 138 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K844002 (1984). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −1 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| 0 (this device) | K152743 | M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) | Microline Surgical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KCT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KCT device
- #1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980065 | C/T Med-Systems Cassette SystemSummary page 4…ion Medical Specialty: General Hospital Predicate Device(s): C/T Med-Systems Cassette System (K980065) Device Description: Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog #3706) intended purpose is to secure th… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 17.7 years on median.
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K980065.
How does its category compare?
All KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 2025
MAUDE reports naming product code KCT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 199 | 0 | 2 |
| 2008 | 6 | 182 | 0 | 8 |
| 2009 | 6 | 89 | 0 | 5 |
| 2010 | 12 | 202 | 1 | 3 |
| 2011 | 6 | 117 | 2 | 3 |
| 2012 | 10 | 236 | 0 | 2 |
| 2013 | 8 | 131 | 1 | 6 |
| 2014 | 11 | 169 | 1 | 5 |
| 2015 | 15 | 151 | 0 | 6 |
| 2016 | 12 | 182 | 3 | 16 |
| 2017 | 10 | 211 | 1 | 3 |
| 2018 | 15 | 192 | 0 | 22 |
| 2019 | 18 | 187 | 0 | 15 |
| 2020 | 14 | 134 | 0 | 66 |
| 2021 | 18 | 185 | 1 | 26 |
| 2022 | 11 | 137 | 17 | 8 |
| 2023 | 10 | 94 | 0 | 30 |
| 2024 | 8 | 106 | 0 | 18 |
| 2025 | 11 | 205 | 0 | 50 |
| 2026 | 9 | 122 | 0 | — |
What is it indicated for?
Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is intended to protect the M/L-10 Clip Applier handpiece (Catalog #1002) and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap, sterility of the enclosed sterilization tray (Catalog# 3706) is maintained until used. The Microline Surgical M/L-10 Clip…
Read the full statement (180 words)
Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is intended to protect the M/L-10 Clip Applier handpiece (Catalog #1002) and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap, sterility of the enclosed sterilization tray (Catalog# 3706) is maintained until used.
The Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is used to secure the M/L-10 Clip Applier handpiece (Catalog #1002) which measures at 17.13" length, 4.94" height, and 0.90"width in dimensional measurements, as the intended load during the transport, sterilization and storage between its intended uses.
The M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the M/L-10 Clip Applier handpiece (Catalog #1002) wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing a calculated total weight of 1663.10 grams. The M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the following Steam Sterilization Parameters: Pre-vacuum, Time: 4 minutes at Temperature of 132 °C. The Gravity Cycle parameters include: Time: 15 minutes and Temperature of 132 °C.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152743: M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152743
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026